Exploratory Clinical Study of Low-dose Radiotherapy Combined With Concurrent Chemotherapy, Toripalimab and Tifcemalimab in First-line Treatment of Extensive-Stage Small Cell Lung Cancer

Sichuan University0 sites12 target enrollmentJanuary 10, 2025

ConditionsExtensive-stage Small-cell Lung Cancer

InterventionsLow-dose radiotherapy Tifcemalimab injection Toripalimab Cisplatin Carboplatin Etoposide

DrugsTifcemalimab injection Toripalimab Cisplatin Carboplatin Etoposide

Overview

Phase: Phase 1
Intervention: Low-dose radiotherapy
Conditions: Extensive-stage Small-cell Lung Cancer
Sponsor: Sichuan University
Enrollment: 12
Primary Endpoint: Number of Participants with Dose-limiting Toxicitys (DLTs)
Status: Withdrawn
Last Updated: 3 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

To evaluate the tolerability and safety of Low-dose radiotherapy combined with concurrent Chemotherapy, Toripalimab and Tifcemalimab in first-line treatment of Extensive-Stage Small Cell Lung Cancer, and to determine the RP2D.

Detailed Description

This is a single-center, single-arm, exploratory clinical study to evaluate the safety and tolerability of low-dose radiotherapy (LDRT) concurrent chemotherapy combined with toripalimab and Tifcemalimab (JS004) in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Approximately 6-12 subjects were planned to be enrolled in this clinical study. The study will adopt a "3 + 3" dose escalation design, and the observation period for dose-limiting toxicities (DLTs) is 21 days after the first dose administration. Patients who meet the inclusion criteria will receive toripalimab 240 mg q3w, tifcemalimab 100 mg or 200 mg q3w until disease progression or intolerable toxicity; cisplatin for injection 75 mg/m2 or carboplatin AUC = 5, q3w, etoposide 100 mg/m2, d1, d2, d3, q3w for 4-6 cycles; low-dose radiotherapy with a total dose of 15 Gy, radiotherapy will be started on Cycle 1 Day 1 in 5 divided doses (15 Gy/5F).

Registry

clinicaltrials.gov

Start Date

January 10, 2025

End Date

February 29, 2028

Last Updated

3 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sichuan University

Responsible Party

Principal Investigator

You Lu

Professor

Sichuan University

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years, male or female;
•Histologically or cytologically confirmed extensive stage small cell lung cancer;
•Previously untreated extensive stage small cell lung cancer;
•ECOG PS 0-1;
•Measurable lesions according to RECIST 1.1, and measurable lesions can only be included in previously irradiated lesions if the lesion shows definite disease progression after radiotherapy;
•Expected survival ≥ 3 months;
•Normal function of major organs, that is, meet the following criteria: neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L; serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min; serum total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ALT and AST ≤ 5 × ULN in patients with liver metastases; international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN unless the subject is receiving anticoagulant therapy, activated partial thrombin time (aPTT) ≤ 1.5 × ULN unless the subject is receiving anticoagulant therapy;
•Female subjects of childbearing potential, as well as male subjects with partners of childbearing potential, need to use a medically recognized contraceptive (such as an intrauterine device, contraceptive, or condom containing spermicide) during study treatment and for at least 4 months after the last use of study drug;
•Voluntary participation in this study, signed informed consent, good compliance, with follow-up.

Exclusion Criteria

•Mixed SCLC and non-small cell lung cancer (NSCLC);
•Symptomatic, untreated or progressive central nervous system (CNS) metastases;
•Received any systemic anti-tumor therapy for ES-SCLC;
•Previously received any immune checkpoint inhibitors, including but not limited to CTLA-4 inhibitors, PD-1/PD-L1 inhibitors, BTLA inhibitors;
•Known hypersensitivity to the study drug or excipients, known serious allergic reactions to any monoclonal antibody;
•Pulmonary artery invasion;
•History of leptomeningeal disease;
•Uncontrollable tumor-related pain;
•Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
•Uncontrolled or symptomatic hypercalcemia;